Press Release: Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA Emergency Use Authorization

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-- The test uses highly sensitive PCR technology, requiring only a single
nasal-swab sample to provide rapid, accurate qualitative detection and
differentiation among four of the most prevalent respiratory viruses for
which differential diagnosis can drive appropriate treatment.

-- Enables healthcare professionals to make confident clinical decisions and
promptly determine appropriate treatment, with definitive results
reported in just 20 minutes.

-- Expands Roche's extensive molecular point of care testing portfolio,
offering greater flexibility to meet testing needs amid evolving regional
prevalence of respiratory infections.
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Basel, 10 June 2024 -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas(R) liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR) assay on the cobas(R) liat system. Producing results in just 20 minutes on a compact analyser suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV).

Diagnostics play a critical role in the fight against respiratory illness," said Matt Sause, CEO of Roche Diagnostics. "We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes."

Introducing rapid multiplex PCR diagnostic tests into near-patient care environments such as emergency departments, urgent care facilities, and physician office labs has the potential to provide swift and precise results, expediting clinical decision-making processes. This approach can help reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, and ultimately enhance patient outcomes and healthcare system efficiency.(1-6)

According to the U.S. Centers for Disease Control and Prevention (CDC), respiratory diseases in the United States reached high levels during the most recent autumn and winter seasons, with SARS-CoV-2 causing the most emergency department visits.(7) Hospitalisations due to respiratory illness place a strain on hospitals and can result in delayed diagnosis and treatment for patients.(8) In the 2023-2024 respiratory season, infants, children, and adults ages 65 and older were observed to have the highest rates of emergency department visits and hospitalisations caused by SARS-CoV-2, influenza, and RSV.(9,10) Nationwide, the percentage of recent total deaths due to these respiratory viruses was highest among patients 65 and older.(11)

The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test authorised for emergency use further expands and complements Roche's broad portfolio of single and multiplex tests intended to help diagnose and address the needs of patients presenting with symptoms of respiratory illness, including the following assays: cobas(R) SARS-CoV-2, cobas(R) Strep A, cobas(R) SARS-CoV-2 & Influenza A/B, and cobas(R) Influenza A/B & RSV for use on the cobas liat system. In 2025, Roche intends to seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver in the United States for the new test, with plans for commercial launch in other markets worldwide following CE-IVDR approval.

About the cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test(12)

The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in anterior nasal (nasal) swab and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. --263a, that meet requirements to perform high, moderate or waived complexity tests. The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is authorised for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Results are for the simultaneous detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV viral RNA in clinical specimens and are not intended to detect influenza C virus. SARS-CoV-2, influenza A, influenza B and RSV RNA are generally detectable in nasal swab and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B and/or RSV RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent detected may not be the definitive cause of disease.

Negative results do not preclude SARS-CoV-2, influenza A, influenza B and/or RSV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for use by trained operators specifically instructed in the use of the cobas liat system and the cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is only for use under the Food and Drug Administration's Emergency Use Authorization.

About the cobas liat system

The cobas liat system combines the cobas liat analyser -- an automated nucleic acid test instrument -- with cobas liat assay tubes to fully automate the testing process, simplify workflows, and enable healthcare professionals to perform molecular testing in a variety of near-patient settings with speed, reliability, and minimal training. The system performs reagent preparation, target enrichment, inhibitor removal, nucleic acid amplification, polymerase chain reaction (PCR) amplification, real-time detection, and result interpretation to automate the detection and quantification of nucleic acid targets in a biological sample in a single closed tube. Definitive results are generated in 20 minutes or less to aid in patient care decisions. The cobas liat SARS-CoV-2, Influenza A/B & RSV Assay complements existing tests for SARS-CoV-2 & Influenza A/B, Influenza A/B & RSV, Strep A, and Cdiff. Assays for other infectious diseases are currently in development. More information is available at https://www.globenewswire.com/Tracker?data=YADsyafYuUY95psBI0F9SzkzZeTtkZzGaHNBb5dPfA9RkUtE3mjmGIrHbPIMB-6EuT7ghfNOHTLsQEzwTt6bljZaPaHvyxMj2_upLGqQm0Q= diagnostics.roche.com. The cobas liat system is commercially available in select markets.

About Roche

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit https://www.globenewswire.com/Tracker?data=K0IR8ZfVpLj2HKSDRhGUBRUf9MqUe7yHm9HSXCGFH94GX6aKIgIu3_831AKAOfZsH9xJCxwqiDW2aY46Gknvrw== roche.com.

All trademarks used or mentioned in this release are protected by law.

References

[1] May L, Robbins EM, Canchola JA, Chugh K, Tran NK. A study to assess the impact of the cobas point-of-care RT-PCR assay (SARS-CoV-2 and Influenza A/B) on patient clinical management in the emergency department of the University of California at Davis Medical Center. J Clin Virol. 2023;68:105597. doi:10.1016/j.jcv.2023.105597.

[2] Hansen GT, Moore J, Herding E, et al. Clinical decision making in the emergency department setting using rapid PCR: Results of the CLADE study group. J Clin Virol. 2018;102:42-49. doi:10.1016/j.jcv.2018.02.013.

[3] Berry L, Lansbury L, Gale L, Carroll AM, Lim WS. Point of care testing of Influenza A/B and RSV in an adult respiratory assessment unit is associated with improvement in isolation practices and reduction in hospital length of stay. J Med Microbiol. 2020;69(5):697-704. doi:10.1099/jmm.0.001187.

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[4] Garvey MI, Wilkinson MAC, Bradley CW, Biggs M, et al. Impact of a PCR point of care test for influenza A/B on an acute medical unit in a large UK teaching hospital: results of an observational, pre and post intervention study. Antimicrob Resist Infect Control. 2019;16;8:120. doi:10.1186/s13756-019-0575-6.

[5] Patel P, Laurich VM, Smith S, Sturm J. Point-of-Care Influenza Testing in the Pediatric Emergency Department. Pediatr Emerg Care. 2020;36(11):515-518. doi:10.1097/PEC.0000000000002250.

[6] Youngs J, Marshall B, Farragher M, et al. Implementation of influenza point-of-care testing and patient cohorting during a high-incidence season: a retrospective analysis of impact on infection prevention and control and clinical outcomes. J Hosp Infect. 2019;101(3):276-284. doi:10.1016/j.jhin.2018.11.010.

[7] Centers for Disease Control and Prevention. Public Health and Surveillance Data. RESP-LENS Interactive Dashboard. Accessed May 28, 2024. https://www.globenewswire.com/Tracker?data=r3Lgsv1e-u6GcQlgoJfipheTO-9Qvq9ofpSEmrDg3SwotIOiXFM7KBfDtQdlk_3LC6zE_8EBChXXb7cm4Hmjq0a0UyR1DmIhaXBBnALyGBO0CvA8Lr06EP0X_SRb7ZYO_Um2SnBAZ7Ht_56Yh_IdXOmtai2-RymP4_amPdV1GIp-AkwHkaCGP9tXStVErR3NwsEANGoTa7AhAXDZSkKkyBIPxLDDkv2SQ9PYYDY3M9lK-1yrxlL889ehJY5f9RmVbC42j41MX3Zf2h45NhJtFrGqhAXon3EMBCzLlFf7246VD-vBW4QMnfyZh-WCIrWqBpAXYIKWIXe2YmCewGnBnQ== https://www.cdc.gov/resp-lens/dashboard/?CDC_AAref_Val=https://www.cdc.gov/surveillance/resp-lens/dashboard.html

[8] Centers for Disease Control and Prevention. Respiratory Illnesses. CDC Respiratory Virus Updates. Published January 12, 2024. Accessed January 24, 2024. https://www.globenewswire.com/Tracker?data=r3Lgsv1e-u6GcQlgoJfipheTO-9Qvq9ofpSEmrDg3SyI-SJr7DgYAsKE6ORx8iHTjLKDAgDtDVoCbJQCeAbY3GUKnJo8iBA5tAafDnil_wq3UMhp3l9hjSVW5WPWZEZDDYkz_VyrVkmkmo37vOSuzM8HjuClYxO1hjfiBqpwJ4gqZ6p4u7alWWTPlBpBRJK-zNnrCSOiO5CBvPhl9l5yzOh42D52HSnuNthgcapDf6CojBlLduTmlT2dmivDs2Ag https://www.cdc.gov/respiratory-viruses/whats-new/track-hospital-capacity.html

[9] Centers for Disease Control and Prevention. Respiratory Illnesses. Groups Most Impacted--Emergency Department Visits. Published February 9, 2024. Accessed February 13, 2024. https://www.globenewswire.com/Tracker?data=r3Lgsv1e-u6GcQlgoJfipheTO-9Qvq9ofpSEmrDg3SyI-SJr7DgYAsKE6ORx8iHTYJ6iY1PbH22gtbEF2yQYvTCJ-Bl4wvATD7lpEl5mItCRs70_Qlpjnqql2eq9CVM2C-NkhohI55jbZlDayH4aQSH8t4I0tVDKuWimrn88geR6x_qLGCkyOWAKX5XLPqPQOjqXvWyLHyN8_3DAOjwqzeVDyMs5VpInhcNFBQhCocQum8oaewkG-cFRRGMp0sVmH8_G8U2vBSnkOYI9NKeFLr99KAX27HoeaKvU8PwSlxvATxwvHab4fj0t4EacMQ8OzShz3cnw7hGmb0xufrGi8A== https://www.cdc.gov/respiratory-viruses/data-research/dashboard/most-impacted-emergency-department-visits.html

[10] Centers for Disease Control and Prevention. Respiratory Illnesses. Groups Most Impacted--Hospitalizations. Published February 9, 2024. Accessed February 13, 2024. https://www.globenewswire.com/Tracker?data=r3Lgsv1e-u6GcQlgoJfipheTO-9Qvq9ofpSEmrDg3SyI-SJr7DgYAsKE6ORx8iHTYJ6iY1PbH22gtbEF2yQYvTCJ-Bl4wvATD7lpEl5mItBlywUDNt0A1nAscMn-kQnE-4-O7QsoC_gz2q79yjUnnWidzweJRmWEm16_ygkOkNiqLDyNkrk6Fbdk7guBBJgasc8P1AQj3LF7oSZH82lFP9AFL6KdQQFXy8PPkZDZf8d7smjmYzEVj9ApaOpfLPFg6o5JGVhd5TkrjUjtPQ4E9kN5BWqdCiOdEOFnr-LS_OEjFvSVlY5UU_wGLxwZnLEM https://www.cdc.gov/respiratory-viruses/data-research/dashboard/most-impacted-hospitalizations.html

[11] Centers for Disease Control and Prevention. Respiratory Illnesses. Groups Most Impacted--Deaths. Published May 24, 2024. Accessed May 28, 2024. https://www.globenewswire.com/Tracker?data=r3Lgsv1e-u6GcQlgoJfipheTO-9Qvq9ofpSEmrDg3SyI-SJr7DgYAsKE6ORx8iHTYJ6iY1PbH22gtbEF2yQYvTCJ-Bl4wvATD7lpEl5mItBlywUDNt0A1nAscMn-kQnE-4-O7QsoC_gz2q79yjUnnedgT74mBzxRivuDh2j6ZY66Rb4yCZeWSCdBh4dcNHvfeftMU-1YQ5GWBNATH47RMIP6reHtyTZ5_YG0hFlxMp1XQwep6qz7dFlZELi98UTi9Tc16OdMDRdk7558O-ArXabgdrBokNHmgNIQEpCte0DfNsho3QTJ-G0vce2D84RJ https://www.cdc.gov/respiratory-viruses/data-research/dashboard/most-impacted-hospitalizations.html

[12] This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. --263a, to perform high, moderate or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, influenza B, and RSV, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. -- 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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